NCT03102047 is a Phase 2 clinical trial of durvalumab in Rectal Cancer, sponsored by NSABP Foundation Inc.

Who is sponsoring NCT03102047?

NCT03102047 is sponsored by NSABP Foundation Inc.

What drugs are being tested in NCT03102047?

Interventions in NCT03102047: durvalumab.

What condition does NCT03102047 study?

NCT03102047 studies Rectal Cancer.

Is NCT03102047 still recruiting?

NCT03102047 is currently completed. Last updated 20 April 2022.

Last reviewed 2022-04-20 · How we verify

NCT03102047

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Durvalumab (MEDI4736) After Chemo-Radiation for Microsatellite Stable Stage II-IV Rectal Cancer

Completed Phase 2 Last updated 20 April 2022

What this trial tests

Phase 2 trial testing durvalumab in Rectal Cancer in 45 participants. Completed in 30 December 2021.

Timeline

14 May 2018

Primary endpoint
22 February 2021

30 December 2021

Quick facts

Lead sponsor	NSABP Foundation Inc
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	14 May 2018
Primary completion	22 February 2021
Estimated completion	30 December 2021
Sites	43 locations across United States

Drugs / interventions tested

durvalumab — full drug profile →

Conditions studied

Rectal Cancer — all drugs for Rectal Cancer →

Sponsor

NSABP Foundation Inc

Who can join

18 and older, any sex, with Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is being done to look at the safety and response to the investigational drug durvalumab (MEDI4736) following chemo-radiation therapy for patients with MSS stage II to IV rectal cancer. Durvalumab recognizes specific proteins on the surface of cancer cells and triggers the immune system to destroy the cancer cells. The chemoRT portion of the treatment will be completed just before the course of durvalumab is initiated. In order to learn more about certain characteristics of rectal cancer tumors, this study includes special research tests using samples from diagnostic tumors, a tissue sample from tumors removed during surgery, fresh tumor samples from an area where the cancer has recurred, and blood samples.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Comprehensive review of targeted therapy for colorectal cancer.
Xie YH, Chen YX, Fang JY. · · 2020 · cited 1162× · PMID 32296018 · DOI 10.1038/s41392-020-0116-z
Immunotherapy efficacy on mismatch repair-deficient colorectal cancer: From bench to bedside.
Lizardo DY, Kuang C, Hao S, Yu J, et al · · 2020 · cited 160× · PMID 33035640 · DOI 10.1016/j.bbcan.2020.188447
The theory of tumor ecosystem.
Chen X, Song E. · · 2022 · cited 93× · PMID 35642770 · DOI 10.1002/cac2.12316
Immunotherapy with immune checkpoint inhibitors in colorectal cancer: what is the future beyond deficient mismatch-repair tumours?
Huyghe N, Baldin P, Van den Eynde M. · · 2020 · cited 79× · PMID 32104582 · DOI 10.1093/gastro/goz061
Is There a Place for Immunotherapy for Metastatic Microsatellite Stable Colorectal Cancer?
Ghiringhelli F, Fumet JD. · · 2019 · cited 61× · PMID 31447840 · DOI 10.3389/fimmu.2019.01816
Clinical significance of soluble programmed cell death-1 and soluble programmed cell death-ligand 1 in patients with locally advanced rectal cancer treated with neoadjuvant chemoradiotherapy.
Tominaga T, Akiyoshi T, Yamamoto N, Taguchi S, et al · · 2019 · cited 45× · PMID 30807610 · DOI 10.1371/journal.pone.0212978
Recent Advances in the Clinical Development of Immune Checkpoint Blockade Therapy for Mismatch Repair Proficient (pMMR)/non-MSI-H Metastatic Colorectal Cancer.
Lee JJ, Chu E. · · 2018 · cited 41× · PMID 30072278 · DOI 10.1016/j.clcc.2018.06.004
Neoadjuvant immunotherapy for colorectal cancer: Right regimens, right patients, right directions?
Zhu J, Lian J, Xu B, Pang X, et al · · 2023 · cited 38× · PMID 36949951 · DOI 10.3389/fimmu.2023.1120684

Verify or expand the search:

Other trials of durvalumab

Trials testing the same drug.

NCT06694454 — Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immun · Phase 1, PHASE2 · not yet recruiting
NCT05924880 — A Phase 3b, Open-label, Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as 1L Treatm · Phase 3 · completed
NCT05683977 — A French Real-life Study: EvaluatioN of durvALumab Utilization and Effectiveness for First Line Extensive Stage Small Ce · active not recruiting
NCT05298423 — Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizuma · Phase 3 · active not recruiting
NCT05043090 — Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced · Phase 3 · active not recruiting

Other recruiting trials for Rectal Cancer

Currently open trials in the same condition.

NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
NCT07537998 — Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a · Phase 2, PHASE3 · recruiting
NCT07501845 — Registry Maastro Applicator · recruiting
NCT07369531 — The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-pres · NA · recruiting
NCT07505472 — Efficacy and Safety Comparison of Short-course Radiotherapy Followed by CapeOX Chemotherapy Plus Toripalimab With or Wit · Phase 2, PHASE3 · recruiting

Other NSABP Foundation Inc trials

Trials by the same sponsor.

NCT07058012 — A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel · Phase 2 · not yet recruiting
NCT03628066 — Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Br · Phase 2 · completed
NCT03457896 — Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Col · Phase 2 · unknown
NCT03412643 — Study of Neoadjuvant Chemotherapy Plus Trastuzumab and Pertuzumab in HER2-Negative Breast Cancer Patients With Abnormal · Phase 2 · unknown
NCT03281954 — Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer F · Phase 3 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03102047 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NSABP Foundation Inc
Last refreshed: 20 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03102047.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing